Clinical Investigation of the Medtronic Concerto™ Device
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Purpose
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).
Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.
| Condition | Intervention |
|---|---|
|
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation |
Device: Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device) |
- Complication rate
- Atrial defibrillation effectiveness
- Change in patient health status during the study
- System performance
- Adverse events
| Estimated Enrollment: | 270 |
| Study Start Date: | January 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who require the implantation of an Implantable Cardioverter Defibrillator
- Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
- Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)
Exclusion Criteria:
- Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
- Subjects who are post-heart transplant
Contacts and Locations
Show 51 Study Locations| Investigator: | Not required for IDE studies |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00268320 History of Changes |
| Other Study ID Numbers: | 230 |
| Study First Received: | December 21, 2005 |
| Last Updated: | September 22, 2008 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Medtronic Cardiac Rhythm Disease Management:
|
congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Fibrillation Heart Failure Tachycardia Atrial Premature Complexes |
Heart Diseases Cardiovascular Diseases Pathologic Processes Cardiac Complexes, Premature |
ClinicalTrials.gov processed this record on June 18, 2013